Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial)
Author:
Maehara Kosuke, Esaki Mitsuru, Sumida Yorinobu, Yamaguchi Daisuke, Nishioka Kei, Homma Hitoshi, Inada Taisuke, Shiotsuki Kazuo, Fukuda Shin-Ichiro, Akiho Hirotada, Nomura Tadahiro, Mizuta Yumi, Ishida Satoshi, Fujimoto Shun, Kimura Shunichiro, Tanaka Yuichiro, Hata Kaori, Shiga Noriko, Iwasa Tsutomu, Kimura Yusuke, Nakamura Norimoto, Suzuki Yusuke, Minoda Yosuke, Hata Yoshitaka, Ogino Haruei, Tagawa Koshiro, Ihara EikichiORCID, Ogawa Yoshihiro
Abstract
Abstract
Background
Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD.
Methods
This multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study.
Discussion
This trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures.
Trial registration
The trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
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